Quality & complianceOfficial

FDA lists Class II recall of Brandywine's theophylline extended-release tablets over stability testing lapse

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The recall, numbered D-0111-2027, stems from an interruption in an ongoing stability programme at a third-party laboratory and covers nationwide US distribution.

The US Food and Drug Administration has published a Class II drug recall for Theophylline Extended-Release Tablets made by Brandywine Pharmaceuticals, LLC. The entry appears in the agency's enforcement report dated 4 November 2026 under recall number D-0111-2027.

The reason given is a current good manufacturing practice (CGMP) deviation: an interruption in the ongoing stability testing programme, which was being run at a third-party laboratory. The record available to us does not describe how long the interruption lasted, which batches or time points were affected, or whether any test results were out of specification.

The recall status is listed as ongoing. Distribution is described as nationwide within the United States. The text provided does not give lot numbers, quantities, expiry dates or the date the recall was initiated, so the scope at batch level cannot be confirmed from this item.

For context, an FDA Class II classification is used where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams that outsource stability studies should check that contract laboratories have robust continuity arrangements, since a gap in an ongoing programme can itself trigger a CGMP-based recall.
  • Regulatory affairs staff should review the full enforcement report entry for lot and quantity details, which are not included in the summary information.
  • Companies with Brandywine theophylline products in their supply chain should confirm their status against recall D-0111-2027 and follow any firm or FDA instructions.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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